part 7 by: soldier30 11/12/01 09:00 pm Msg: 1298 of 1302 In our view, the initial data reported in the three ASH abstracts supports the utility of the TCell-HDM system for use as a tool to decrease the occurrence of GvHD and the use of the AlloMune System for the treatment of hematologic cancers. In the first abstract, investigators examined the use of CD8 T-cell depletion in an 18 patient study as a means to decrease the rate of GvHD in patients receiving donor lymphocyte infusions (DLI). Specifically, this randomized trial examined the impact of CD8 T-cell depletion on GvHD and graft versus tumor responses. Importantly, the results from the study indicate that CD8 T-cell depletion reduces the incidence of GvHD associated with DLI without compromising anti-tumor activity or immunologic recovery. We are encouraged by the initial results reported and believe they support the use of BioTransplant's TCell-HDM system in this therapeutic setting. Two additional abstracts report results using a prototype AlloMune Systems for the treatment of refractory non-Hodgkin's lymphoma (NHL) in a 69 patient study and refractory B cell lymphoma (BCL) in a 20 patient study.
In the NHL study, of 69 patients, 46 received a stem cell transplant (SCT) from an HLA-matched donor, while 23 received an HLA-mismatched donor transplant. Initial mixed chimerism (MC) was demonstrated in all evaluable patients. Forty-nine patients maintained MC or converted to full donor chimerism (FDC). Importantly, 17 of 49 (35%) patients who maintained donor chimerism achieved a complete response (CR) or CR with residual radiologic abnormality compared with four of 20 (20%) patients who lost donor chimerism. The BCL study, evaluated non-myeloablative bone marrow transplantation in 20 patients with advanced BCL. The results indicate that 8 of 19 evaluable patients achieved a response (5 CR, 3 PR) including 3 of 10 HLA matched patients and 5 of 10 HLA mismatched patients. Additionally, five patients were alive, and progression free at 13 to 52 months post-transplant. We are encouraged by these preliminary results and believe they demonstrate the utility of the AlloMune System as a method for the treatment of refractory hematologic cancers. |